Cryopreservation of EmbryosNCT02013024
The Effect of Vitrification Versus Slow Freezing on Day 3: a Randomised Controlled Trial.
A study testing cryopreservation technique in people with Cryopreservation of Embryos, run by Sophie Debrock at 1 site in Belgium.
Trial summary
Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to slow freezing. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cryopreservation of Embryos
- What is being tested?
- cryopreservation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2011to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients (with female age < 40 years)
- Patients undergoing a 1st oocyte retrieval for an IVF/Intracytoplasmatic Sperm Injection (ICSI) treatment
- Patients planned for an embryo transfer on day 3.
- Patients with supernumerary embryos of sufficient quality for freezing/vitrifying on day 3.
- Fresh personal (own oocytes)
- One inclusion in the study per patient.
Who cannot join
- Patients undergoing a 2nd or higher ranked oocyte retrieval after a fresh cycle with failed pregnancy.
- Female age ≥ 40 year
- Patients with Preimplantation Genetic Diagnosis (PGD)
- Patients with donor oocytes
- Patients with positive serology whose embryos may not be frozen.
- Patients planned for a transfer on day 2 or day 5.
- Patients receiving assisted hatching in the embryo transfer in the frozen cycles.
- Patients who have been included in the study before.
Trial locations and contacts
1 site in 1 country.
About this study
Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to slow freezing.
- Conditions
- Cryopreservation of Embryos
- Being tested
- cryopreservation technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryopreservation techniqueOther
| Study group | Role | What they receive |
|---|---|---|
| cryopreservation technique | Active comparator | slow freezing cryopreservation technique Receives: Other: cryopreservation technique |
| vitrification cryopreservation technique | Active comparator | vitrification cryopreservation technique Receives: Other: cryopreservation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life birth rate per embryo thawed
Measured: 3 years
Secondary outcomes (5)
live birth rate per embryo transferred
Measured: 3
survival rate
Measured: 3 year
implantation rate per embryo transferred
Measured: 3 years
implantation rate per embryo thawed
Measured: 3 years
abortion rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startSep 2011
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cryopreservation of EmbryosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sophie Debrock
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sophie Debrock, KU Leuven
- Investigators
- Thomas M D'Hooghe, Prof Dr, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013024
- Sponsor's protocol ID
- S53410
- Status last verified
- Feb 2015
- First submitted
- 11 Dec 2013
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Debrock S, Peeraer K, Fernandez Gallardo E, De Neubourg D, Spiessens C, D'Hooghe TM. Vitrification of cleavage stage day 3 embryos results in higher live birth rates than conventional slow freezing: a RCT. Hum Reprod. 2015 Aug;30(8):1820-30. doi: 10.1093/humrep/dev134. Epub 2015 Jun 18.
PubMed 26089301
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitrification Versus Slow Freezing on Day 3: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02013024
- Acronym / sponsor ID
- S53410
- Conditions
- Cryopreservation of Embryos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Sophie DebrockUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to slow freezing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cryopreservation technique | Active comparator | Other: cryopreservation techniqueslow freezing cryopreservation technique |
| vitrification cryopreservation technique | Active comparator | Other: cryopreservation techniquevitrification cryopreservation technique |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients (with female age < 40 years)
- Patients undergoing a 1st oocyte retrieval for an IVF/Intracytoplasmatic Sperm Injection (ICSI) treatment
- Patients planned for an embryo transfer on day 3.
- Patients with supernumerary embryos of sufficient quality for freezing/vitrifying on day 3.
- Fresh personal (own oocytes)
Key exclusion criteria (8 listed)
- Patients undergoing a 2nd or higher ranked oocyte retrieval after a fresh cycle with failed pregnancy.
- Female age ≥ 40 year
- Patients with Preimplantation Genetic Diagnosis (PGD)
- Patients with donor oocytes
- Patients with positive serology whose embryos may not be frozen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryopreservation technique | Other | cryopreservation technique, vitrification cryopreservation technique |
Primary outcome
Life birth rate per embryo thawed
Time frame: 3 years
5 secondary outcomes
live birth rate per embryo transferred
Time frame: 3
survival rate
Time frame: 3 year
implantation rate per embryo transferred
Time frame: 3 years
implantation rate per embryo thawed
Time frame: 3 years
abortion rate
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
- Derived from this study: PubMed 26089301Debrock S, Peeraer K, Fernandez Gallardo E, De Neubourg D, Spiessens C, D'Hooghe TM. Vitrification of cleavage stage day 3 embryos results in higher live birth rates than conventional slow freezing: a RCT. Hum Reprod. 2015 Aug;30(8):1820-30. doi: 10.1093/humrep/dev134. Epub 2015 Jun 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas M D'Hooghe, Prof Dr principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryopreservation technique in people with Cryopreservation of Embryos, run by Sophie Debrock at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life birth rate per embryo thawed (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02013024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.